NCT06438250

68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies

68Ga-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

68Ga-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer.

Detailed description

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-JH04.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	68Ga-JH04	The dose will be 148-222 MBq given intravenously.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-05-01
• Completion: 2025-12-31
• First posted: 2024-05-31
• Last updated: 2024-11-14

Locations

1 site across 1 country: China